FSSAI has drafted the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2019 related to insertion of Appendix ‘C’ regarding Processing Aids. The FSSAI has also invited suggestions and objections on the proposed draft, which can be mailed to [email protected] on or before 11 March 2019

Draft regulations

These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives) Amendment Regulations, 2019. They shall come into force on the date of their publication in the Official Gazette.

In the Food Safety and Standards (Food Products Standards and Food Additives) regulations, 2011, the FSSAI proposes to add Processing Aids in Chapter 3 relating to SUBSTANCES ADDED TO FOOD.

3.4 PROCESSING AIDS

Processing aids included in these Regulations

The processing aids listed herein are recognised as suitable for use in foods in conformance with the provisions ofthese regulations and have been assigned an Acceptable Daily Intake (ADI) or determined (wherever applicable), onthe basis of other criteria, to be safe and the use of processing aids in conformance with these regulations has to betechnologically justified.

Product category: The foods or food processing procedures, in which the processing aid is utilised, are defined by these regulations.

Food in which processing aids may be used: The conditions, under which processing aids may be used in foods, are defined by these Regulations.

Foods in which processing aids may not be used: Unless expressly permitted in these regulations, processing aids must not be added to food.

Processing aid means any substance or material, not including apparatus or utensils, and not consumed as afood ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients, to fulfil acertain technological purpose during treatment or processing and which may result in the non-intentional butunavoidable presence of residues or derivatives in the final product (as per FSS Act 2006).

Acceptable Daily Intake (ADI) means the amount of a processing aid in food expressed on a body weight basisthat can be ingested daily over a lifetime without appreciable health risk and a processing aid, meeting this criterionshall be used within the bounds of Good Manufacturing Practice (GMP) as specified in clause below

Maximum permitted Level of a processing aid, is the highest concentration of the processing aid, determined tobe functionally effective in a food or food category and agreed to be safe and it is generally expressed as mg/kg offood.

Residual level means the level of processing aid remaining in food after processing. The levels should bedesignated with respect to those directly measured by analysis or estimated by other means. Values are in mg/kg andvalues at the detection limit of available analytical procedures are reported as “Not more than”.

EC number (Enzyme Commission number) means the number which the Enzyme Commission uses toclassify the principal enzyme activity.

Justification for the use of Processing Aids: The use of a substance as a processing aid is justified when such use performs one or more technological functionsduring treatment or processing of raw materials, foods, or ingredients. Any residues of processing aids remaining inthe food after processing should not perform a technological function in the final product.

Good Manufacturing Practice (GMP)

All the processing aids subject to the provisions of these regulations shall be used under conditions of goodmanufacturing practices (GMP) which includes the following.

(a) The quantity of the substance used shall be limited to the lowest achievable level necessary to accomplish its desired technological function;

(b) Residues or derivatives of the substance remaining in food should be reduced to the extent reasonably achievable and should not pose any health risk, and

(c) The substance is prepared and handled in the same way as a food ingredient.

Specifications for the Identity and Purity of processing aidsSubstances used as processing aids should be of food grade quality. This can be demonstrated by conforming to theapplicable specifications of identity and purity recommended under these Regulations, and in case such standardsare not specified, the purity criteria accepted by international bodies such as Codex Alimentarius may be adhered to.The safety of a substance used as a processing aid should be demonstrated by the supplier or the user of thesubstance. The demonstration of safety should include an appropriate assessment of any unintended or unavoidableresidues resulting from its use as a processing aid under conditions of GMP.

Conditions for Labelling

The product covered by this Standard shall be labelled in accordance with the Food Safety and Standards(Packaging & Labelling) Regulation, 2011. The INS number of the processing aids wherever available or the name of the processing aids wherever INS number is

not available on the product should also be mentioned and declaration of the vegetarian or non-vegetarian logo, irrespective of the residue level to be mentioned in the label.

3.4.2 PROCESSING AIDS CATEGORIES

Antifoaming Agents: Substances that reduce and hinder the formation of foam in the processing of liquid food products.

Catalyst: Substances that increase the rate of a chemical reaction without itself undergoing any permanent chemical change.

Clarifying Agents and Filtration Agents: Substances that are used to remove suspended solids from liquids by inducing flocculation and those substances which aid in the process of filtration.

Lubricants, Release and Anti-stick Agents: Substances which help to reduce friction between food contact surfaces and substances that provide the critical barrier between moulding surface and the substrate facilitating separation of cured part from the mould.

Microbial Control Agents: Substances that can be used to inactivate spoilage organisms in the processing of foods.

Microbial Nutrients and Microbial Nutrient Adjuncts: Substances that can be used to enhance the growth of the microbial culture intended to be used in food processing.

Solvent for Extraction and Processing: Processing aids that help in the separation of a particular substance from a mixture by dissolving that substance in a solvent that will dissolve it, but which will not dissolve any other substance in the mixture.

Bleaching, Washing, Peeling and Denuding Agents: Substances that can be used in making food products white or colourless and substances that aid in surface treatment (washing, denuding and peeling)of food specified in these regulations.

Flocculating Agents and Enzyme Immobilization Agents and Supports: Substances that promote flocculation by causing colloids and other suspended particles in liquids to aggregate and forming a floc. Flocculants are used to improve the sedimentation or filterability of small particles.

Contact Freezing and Cooling Agents: Substances that can cause rapid freezing on contact with food.

Desiccating Agent: Substances that extract water and prevent the formation of lumps during the manufacturing of food products. They are either soluble or insoluble substances that adsorb water due to their chemical properties.

Enzymes: These are macromolecular biological catalysts which accelerate chemical reactions in the treatment or processing of raw materials, foods, or ingredients. The enzymes may be used as a processing aid to perform any technological purpose if the enzyme is derived from the corresponding source specified in the table.

Generally, Permitted Processing AidsThis category includes processing aids which have different technological functions. These shall be used as per the conditions specified in the corresponding table under these regulations.

Processing Aids for “Beer and Malt Beverages”, “Aromatized Alcoholic Beverages” and“Wines” This category includes processing aids which may be used in the course of manufacture of beer, malt beverages, aromatized alcoholic beverages, and wines. These shall be used as per the conditions specified in the corresponding table under these regulations.

Note: The processing aids listed in the Table 1 to 13 may be used in the course of manufacture of food specified in the corresponding table provided the final food contains no more than the corresponding residue level specified in the Table.